EIK1003 / IMPACT Therap, Eikon Therap - LARVOL DELTA

A first-in-human (FIH), phase 1/2, dose-escalation, dose-optimization, and dose-expansion study of PARP1-selective inhibitor EIK1003 as monotherapy and in combination in patients with advanced solid tumors (AACR 2025) - "EIK1003 (IMP1734) is a potent PARP1-selective inhibitor that inhibits tumor growth in nonclinical models and may widen the therapeutic index in tumors where nonselective PARPi have demonstrated efficacy. Study EIK1003-001 (IMP1734-101) is a global, multi-center, Phase 1/2 study evaluating the safety and potential antitumor activity of EIK1003 as monotherapy and in combination with abiraterone or paclitaxel in patients with advanced solid tumors (NCT#06253130). Exploratory endpoints include analysis of pharmacodynamic biomarkers and serial circulating tumor DNA (ctDNA) measurements. This study opened on 11 Dec 2023."

Clinical • Metastases • Monotherapy • P1/2 data • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • BRCA1 • BRCA2 • HRD • PARP2

Safety and efficacy of EIK1003, a selective PARP1 inhibitor, as monotherapy in participants with advanced solid tumors. (ASCO 2025) - "Funded by No funding sources reported Clinical Trial Registration Number: 06253130 Background: PARP inhibitors (PARPi) selectively kill tumor cells with genetic mutations in critical DNA repair genes (eg, BRCA1/2). To date, EIK1001 has demonstrated tolerable safety and encouraging preliminary efficacy. Dose escalation is ongoing. Updated safety and efficacy data will be reported at the time of presentation."

Clinical • Metastases • Monotherapy • Anemia • Breast Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • HER-2 • HRD • MUC16 • PARP2

Eikon Therapeutics to Share Clinical Data and Program Updates at the 2025 ASCO Annual Meeting (Businesswire) - "Eikon Therapeutics...announced that new data from its oncology programs will be presented in collaboration with independent investigators at the American Society of Clinical Oncology (ASCO) Annual Meeting....The...posters will spotlight new first-in-human and combination data from Eikon’s two most advanced clinical programs."

Clinical protocol • P1/2 data • Melanoma

Eikon Therapeutics Secures $350.7 Million Series D to Advance Clinical-Stage Programs and Future Pipeline (Businesswire) - "Eikon Therapeutics, Inc...announced the initial closing of a $350.7 million Series D financing. Since its founding in 2019, Eikon Therapeutics has privately raised in excess of $1.1 billion to support its mission of developing new medicines to address grievous illnesses....Eikon’s clinical portfolio is anchored by its lead program, EIK1001, a systemically administered co-agonist of toll-like receptors 7 and 8 now in a Phase III trial for advanced melanoma.... In parallel, the company is advancing EIK1003, a highly selective PARP1 inhibitor currently undergoing Phase 1 evaluation in patients with breast, ovarian, prostate, or pancreatic cancers, and EIK1004, a central nervous system-penetrant PARP1-selective inhibitor poised to initiate Phase 1 studies targeting brain cancers. Eikon’s early-stage pipeline features, among other undisclosed candidates, two androgen receptor antagonists and an internally derived WRN inhibitor (EIK1005)..."

Financing • Brain Cancer • Breast Cancer • Melanoma • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer

discovery and development of IMP1734 (EIK1003), a potent and selective PARP1 inhibitor (EORTC-NCI-AACR 2024) - P1/2 | "Overall, IMP1734 is a potent and selective PARP1 inhibitor, with robust anti-tumor activity in vivo and decreased potential for hematologic toxicity, making it a promising candidate for further development as a targeted therapy for cancers either as a monotherapy or as combination therapy. IMP1734 is currently being evaluated in a Phase I clinical trial for solid tumors with select HRR gene mutations."

Breast Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • HRD • PARP2

A first-in-human (FIH), phase 1/2, dose-escalation, dose-optimization, and dose-expansion study of PARP1-selective inhibitor IMP1734 in participants with advanced solid tumors. (ASCO 2024) - P1/2 | "Exploratory endpoints include analysis of pharmacodynamic biomarkers, serial ctDNA measurements, and patient quality-of-life measures. This study opened on 11 Dec 2023."

Metastases • P1/2 data • Genito-urinary Cancer • Hematological Disorders • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • HRD • PARP2

Eikon Therapeutics Announces Multiple Abstracts to be Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting (Businesswire) - "Separate poster presentations will highlight EIK1001 both in combination with pembrolizumab and chemotherapy (trial in progress) and safety and preliminary efficacy in combination with atezolizumab; A Phase 1 study of the PARP1-selective inhibitor, EIK1003, will be highlighted in a poster presentation (trial in progress)."

P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Eikon Therapeutics

New P1/2 trial • Oncology • Solid Tumor

Eikon Therapeutics to Provide Corporate Updates at the 42nd Annual J.P. Morgan Healthcare Conference (Businesswire) - "EIK1001 Advances to Phase 2: Eikon's most advanced candidate, EIK1001, a systemically administered TLR 7 and 8 co-agonist, has received Investigational New Drug Application (IND) clearance from the U.S. Food and Drug Administration (FDA) and has proceeded into the first of several planned Phase 2 trials focused, in this case, on patients with advanced lung cancer when administered in combination with standard-of-care pembrolizumab plus chemotherapy....EIK1003 Now Enrolling Patients: Eikon's selective PARP1 inhibitor, EIK1003, has entered a Phase 1/2 clinical trial at multiple U.S. sites assessing safety and tolerability in adult patients that have received at least one prior PARP inhibitor treatment for specific solid tumors expressing selected deleterious genetic mutations. International sites will join the trial early in 2024."

IND • Trial status • Lung Cancer • Oncology • Solid Tumor

Eikon Therapeutics Announces Business Update, Highlighting Pipeline and Clinical Development Progress (Businesswire) - "Separately, the FDA has cleared IMP1734, a highly selective PARP1 inhibitor developed in partnership with Impact Therapeutics, for Phase 1 study initiation, which will also begin in the fourth quarter."

IND • New P1 trial • Oncology

Impact Therapeutics Entered into Global Partnership with Eikon Therapeutics to Develop and Commercialize PARP1 Selective Inhibitors (PRNewswire) - "IMPACT Therapeutics...and Eikon Therapeutics...announced that the companies have entered into a global license and collaboration agreement for PARP1 selective inhibitors including IMP1734, which is anticipated to enter into Phase I clinical study in 2023. Under the collaboration agreement, Eikon received an exclusive license from Impact to co-develop, register, manufacture, and commercialize IMP1734 and other PARP1 selective inhibitors globally, excluding Greater China (mainland China, Hong Kong, Macau, and Taiwan)."

Licensing / partnership • New P1 trial • Oncology